Senior Mechanical Engineer – Medical Device

Engineering Resource Group, Inc.; Clifton (NJ); On-site; USD 110,000 - 160,000; Full time

Job summary

Engineering Resource Group, Inc. seeks a Senior Mechanical Engineer for long-term contract to support new product development of electromechanical medical devices. You will establish design objectives, author specifications, and review requirements across disciplines.

The role involves developing prototypes, performing verification testing, and leading projects. A BS/MS in Mechanical Engineering is required with 10+ years of experience, SolidWorks preferred, and familiarity with ISO 13485, GMP,

Qualifications

• Requires BS or MS in Mechanical Engineering.
• 10+ years of related mechanical design experience.
• Experience with electromechanical medical devices.
• Strong GD&T and drafting standards knowledge.
• Proficiency with measurement and test equipment.

Responsibilities

• Lead design and development across multiple sub-systems.
• Develop prototypes and test methods for verification.
• Ensure regulatory compliance with ISO 13485 and FDA standards.
• Collaborate across engineering disciplines in 3D CAD modeling.
• Provide technical direction to junior engineers.

Skills

Senior mechanical design

Cross-disciplinary design

Medical device design

DFM&A

GD&T

Thermal analysis

Structural analysis

Test instrumentation

Leadership

Education

BS in Mechanical Engineering

MS in Mechanical Engineering

Tools

SolidWorks

CAD software

Job description

• Long-term contract position for a Senior Mechanical Engineer supporting new product development of electromechanical medical devices and equipment.
• Establish system and component design objectives, author complex specifications and review product requirements.
• Develop solutions to difficult analytical and pneumatic, mechanical and electrical design problems.
• Conduct conceptual design studies in 3D solid modeling CAD and collaborate across engineering disciplines.
• Develop prototypes, test methods, fixtures and prototype tooling using internal manufacturing resources and outside suppliers.
• Develop and execute design verification protocols, analyze test data and issue technical reports against environmental, regulatory and safety requirements.
• Maintain design documentation within an electronic document control system.
• Provide technical direction to junior engineers and serve as lead engineer on small to medium projects.
• BS or MS in Mechanical Engineering.
• Minimum 10 years of related mechanical design and product development experience, including technical supervision of sub-projects.
• Experience with CAD software, SolidWorks preferred.
• Experience designing electromechanical and electro-pneumatic medical devices or capital equipment.
• Working knowledge of DFM&A including cost, tooling and process considerations.
• Design experience across injection molded plastics, extrusions, sheet metal, stampings, castings, machined components and additive manufacturing in high part count assemblies.
• Working knowledge of GD&T, ANSI/ISO dimensioning and drafting standards and statistical analysis of test data.
• Experience with thermal and structural analysis and vibration testing.
• Proficiency with mechanical measurement and test equipment including pressure and flow instrumentation, environmental chambers, PC-based data acquisition, multimeters and oscilloscopes.
• Knowledge of medical device regulations and quality practices including ISO 13485, GMP and applicable FDA, IEC and UL standards for medical electronic equipment.